Surgical devices and related methods thereof

ABSTRACT

The present invention relates to surgical devices and related methods of use. In particular, the present invention relates to surgical devices used for contacting and treating deeply seated areas of the brain.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/638,619, filed Dec. 15, 2009, which application is acontinuation-in-part of U.S. application Ser. No. 11/515,524, filed Sep.5, 2006, now abandoned, which application claims the benefit of U.S.Provisional Application No. 60/757,652, filed Jan. 10, 2006 and U.S.Provisional Application No. 60/713,639, filed Sep. 2, 2005, the entirecontents of which are herein incorporated by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates to surgical devices and related methods ofuse. In particular, the present invention relates to surgical devicesused, for example, for contacting and treating areas of the brain.

BACKGROUND

Brain tumors account for 85% to 90% of all primary central nervoussystem (CNS) tumors (see, e.g., Levin V. A., et al., Cancer: Principlesand Practice of Oncology. 6th ed. Philadelphia, Pa.: Lippincott Williams& Wilkins, 2001, pp 2100-60; herein incorporated by reference in itsentirety). Available registry data from the Surveillance, Epidemiology,and End Results (SEER) database for 1996 to 2000 indicate that thecombined incidence of primary invasive CNS tumors in the United Statesis 6.6 per 100,000 persons per year, with an estimated mortality of 4.7per 100,000 persons per year (see, e.g., Trends in SEER incidence andU.S. mortality using the joinpoint regression program 1975-2000 with upto three joinpoints by race and sex. In: Ries L A G, Eisner M P, KosaryC L, et al.: SEER Cancer Statistics Review, 1975-2000. Bethesda, Md.:National Cancer Institute, 2003; herein incorporated by reference in itsentirety). Worldwide, approximately 176,000 new cases of brain and otherCNS tumors were diagnosed in the year 2000, with an estimated mortalityof 128,000 (see, e.g., Parkin D. M., et al., Int J Cancer 94 (2): 153-6,2001; herein incorporated by reference in its entirety). In general, theincidence of primary brain tumors is higher in whites than in blacks,and mortality is higher in males than in females (see, e.g., Levin V.A., et al., Cancer: Principles and Practice of Oncology. 6th ed.Philadelphia, Pa.: Lippincott Williams & Wilkins, 2001, pp 2100-60;herein incorporated by reference in its entirety).

Metastatic tumors are among the most common mass lesions in the brain.In recent years the incidence of CNS metastasis has increased. This isbecause, for example, the median survival duration of cancer patientshas increased as a result of modem therapies, increased availability ofadvance imaging techniques, and vigilant surveillance protocols.Unfortunately, some chemotherapeutic agents can weaken the blood-brainbarrier (BBB) transiently and allow CNS seeding. Moreover, a number ofcommonly used chemotherapeutic agents do not cross the BBB, thus leavingthe brain as a safe haven for tumor growth. Metastases from systemiccancer can affect brain parenchyma, its covering, and the skull.Different tumors metastasize to different organs preferentially.Generally, cells with similar origins are believed to have similargrowth constraints and to embryologically express similar sets ofadhesive molecules such as addressins. In the United States, incidenceof metastatic brain tumor is exceeding that of primary brain tumor.Metastatic brain tumors comprise 50% of all brain tumors and as many as30% of tumors diagnosed by imaging study alone. The incidence isestimated to be 100,000 new cases per year in the United States. Inautopsy studies, over 20% patients with systemic neoplastic disease havebrain metastasis.

The clinical presentation of various brain tumors is best appreciated byconsidering the relation of signs and symptoms to anatomy (see, e.g.,Levin V. A., et al., Cancer: Principles and Practice of Oncology. 6thed. Philadelphia, Pa.: Lippincott Williams & Wilkins, 2001, pp 2100-60;herein incorporated by reference in its entirety). General signs andsymptoms include headache, gastrointestinal symptoms (e.g., nausea, lossof appetite, and vomiting) and changes in personality (e.g., changes inmood, mental capacity, and concentration). Whether primary, metastatic,malignant, or benign, brain tumors must be differentiated from otherspace-occupying lesions such as abscesses, arteriovenous malformations,and infarction, which can have a similar clinical presentation (see,e.g., Hutter A, et al., Neuroimaging Clin N Am 13 (2): 237-50, x-xi,2003; herein incorporated by reference in its entirety).

Surgery is the treatment of choice for accessible brain tumors.Accessible tumors are those that can be surgically removed withoutcausing severe neurological damage.

Deeply seated tumors (e.g., brain tumors located in the brain stem, thethalamus, the motor area, and the deep areas of gray matter) may beinaccessible, and as such, inoperable. The goal of surgery is to removeall or most of the visible tumor. Many benign tumors are treated only bysurgery. Most malignant tumors require additional treatment. Malignanttumors lack distinct borders. They often invade nearby normal braintissue. Tumor cells may also spread throughout the brain and spine byway of the cerebrospinal fluid. But, even partial tumor removal isbeneficial.

There are several purposes of brain tumor related neurosurgery. Onepurpose of brain tumor related surgery is to remove as much tumor aspossible. Partial brain tumor removal (e.g., debulking) provides reliefof symptoms, improved quality of life, and a smaller tumor burden forother treatment modalities. Brain tumor related neurosurgery alsoassists in establishing an exact diagnosis. For example, removal of asample of tumor (e.g., a tumor biopsy) to be examined under a microscopein the laboratory provides an exact diagnosis. Furthermore, brain tumorrelated neurosurgery provides access for other treatments. For example,during neurosurgery radiation implants or chemotherapy-impregnatedwafers may be delivered to the brain tumor. Biopsy alone is performedwhen the tumor is inoperable or when surgery must be delayed. Resection(e.g., surgical removal of a tumor) is the treatment of choice wheneverpossible.

Neurosurgery, however, demands special considerations. Obtainingsurgical access to brain tumors requires the creation of an opening inthe skull (called a craniotomy). Most often, a craniotomy involves alarge incision and dissection of other soft tissue that results insignificant postoperative pain and discomfort. Furthermore, reachingdeep tumors in the brain requires openings into the surface of the brainitself. This brain dissection and manipulation can result inneurological deficits.

What is needed are improved neurosurgical techniques for accessing brainlocations. Additionally, what are needed are improved devices assistingin neurosurgical techniques that limit soft tissue dissection andpotential brain manipulation and damage.

Additionally, what is needed are improved devices for cutting,cauterizing and aspirating brain tumors through small openings in theskull and brain tissue.

BRIEF SUMMARY

The present invention relates to surgical devices and related methods ofuse. In particular, the present invention relates to surgical devicesused, for example, for contacting and treating areas of the brain,including deeply seated areas. Generally, deeply seated tumors areconsidered inoperable. The present invention, however, provides devicescapable of accessing deeply seated areas of the brain (e.g., braintumors, hematomas, infections) while minimizing the risk of braindamage.

In some embodiments, the present invention provides probe devicescomprising:

a) a tubular central stem, wherein the tubular central stem comprises aproximal portion, a distal portion, and a distal end, wherein aplurality of suction and cutting openings are formed in the distalportion of the tubular central stem, wherein the tubular central stem isconfigured to allow cutting of tissue with the plurality of cuttingopenings, and allow aspiration of the tissue through the plurality ofsuction openings; b) a probe sleeve, wherein the probe sleeve comprisesa proximal portion, and a distal portion, wherein the proximal portionencloses most or all of the proximal portion of the tubular centralstem; c) at least one wire loop, wherein the at least one wire loop isoperably attached to the distal end of the tubular central stem andextends beyond the distal portion of the probe sleeve, and wherein theat least one wire loop is: i) configured for cutting tissue, ii)configured for rotating around the distal portion of the tubular centralstem, and iii) configured to outwardly expand and contract; and d) aloop expander and rotation motor mechanism which is operably linked tothe at least one wire loop and configured to cause rotation and outwardexpansion of the at least one wire loop, wherein the loop expander androtation mechanism is located in the probe sleeve.

In certain embodiments, the present invention provides systemscomprising: a) a probe device comprising: i) a tubular central stem,wherein the tubular central stem comprises a proximal portion, a distalportion, and a distal end, wherein a plurality of suction and cuttingopenings are formed in the distal portion of the tubular central stem,wherein the tubular central stem is configured to allow cutting oftissue with the plurality of cutting openings, and allow aspiration ofthe tissue through the plurality of suction openings; ii) a probesleeve, wherein the probe sleeve comprises a proximal portion, and adistal portion, wherein the proximal portion encloses most or all of theproximal portion of the tubular central stem; iii) at least one wireloop, wherein the at least one wire loop is operably attached to thedistal end of the tubular central stem and extends beyond the distalportion of the probe sleeve, and wherein the at least one wire loop is:A) configured for cutting tissue, B) configured for rotating around thedistal portion of the tubular central stem, and C) configured tooutwardly expand and contract; and iv) a loop expander and rotationmotor mechanism which is operably linked to the at least one wire loopand configured to cause rotation and outward expansion of the at leastone wire loop, wherein the loop expander and rotation mechanism islocated in the probe sleeve; and b) at least one additional componentselected from the group consisting of: i) an energy generatingcomponent, ii) an irrigation supply component; iii) a system controllercomponent; iv) a cannula, wherein the probe is configured to fit throughthe cannula; and v) a mounting mechanism.

In certain embodiments, the energy generating component comprises an RFgenerating component. In other embodiments, the probe is insertedthrough the cannula (e.g., where the depth of insertion determines thesize of the expanded wire loops).

In certain embodiments, the at least one wire loop has a proximalportion and a distal portion, and wherein downward thrust on theproximal portion of the at least one wire by the loop expander androtation motor mechanism causes outward expansion of the at least onewire loop. In other embodiments, the probes further comprise an energygenerator connection (RF connection), wherein the energy generatorconnection is attached to the probe sleeve. In some embodiments, theprobes further comprise an irrigation fluid input port, wherein theirrigation fluid input port is attached to the probe sleeve. Inparticular embodiments, the probes further comprise a vacuum portconnection, wherein the vacuum port connection is attached to the probesleeve. In other embodiments, the probes further comprise a cuttingmotor mechanism, wherein the cutting motor mechanism is attached to thetubular central stem. In additional embodiments, the probes furthercomprise a loop swivel attachment, wherein the at least one wire loop isoperably attached to the distal end of the tubular central stem via theloop swivel attachment.

In some embodiments, the at least one wire loop expands out in ahalf-circle or egg-beater shape. In additional embodiments, the at leastone wire loop comprises two, three, four, five, six, seven, eight, nine,or ten wire loops.

In certain embodiments, the present invention provides a devicecomprising a cannula member. In preferred embodiments, the cannulamember comprises a tubular extension comprising proximal and distalends, the tubular extension having a longitudinal axis and havingtherein a hollow channel parallel to the longitudinal axis, the hollowchannel running the length of the tubular extension through the proximaland distal ends, wherein upon insertion into a bone hole said tubularextension extends beyond said bone hole and into the body cavitysurrounding said bone hole; and an attachment member on the proximalend, the attachment member configured such that as the tubular extensionis inserted into a bone hole the attachment member engages the outsideof the bone hole thereby securing the device within the bone hole. Thecannula member is configured to be inserted into a bone hole at anydesired angle (e.g., 90 degrees, 80 degrees, 45 degrees, 20 degrees).

In some embodiments, the attachment member comprises an overhang portionthat extends beyond the tubular extension, wherein the overhang portionis configured to engage the surface of a bone thereby securing thecannula device within a burr hole. In other embodiments, the overhangportion has therein a plurality of holes configured to receive fasteningagents. In some embodiments, the attachment member configured such thatas the cannula device is inserted into a bone hole such that theattachment member engages the outside of the bone hole thereby securingthe device within the bone hole. The overhang portion may be secured tothe surface of a bone hone hole in any manner (e.g., adhesive glue,threaded fasteners).

In preferred embodiments, the cannula member has therein a removablestylet. The cannula member is not limited to a particular type, size, orshape of stylet. In preferred embodiments, the stylet assists innavigating the cannula member through the brain. In preferredembodiments, the stylet is removed after positioning of the cannulamember within the brain.

In preferred embodiments, the bone hole passes through the bone. Inother preferred embodiments, the material of the cannula devicecomprises polyacetal although any suitable material may be used (e.g.,metals, ceramics, plastics, etc.). In some embodiments, the bone is thecranial bone and the bone hole is a burr hole.

In preferred embodiments, the cannula member further comprises or isassociated with an endoscopic camera or imaging component or navigationsystem that permits or assists in placement, positioning, and/ormonitoring of the device.

The tubular extension is not limited to a particular length. Inpreferred embodiments, the length of the tubular extension is at least 2cm, at least 5 cm in length, and at least 10 cm in length. In otherembodiments, the length of the tubular extension is between 1-5 cm,while in other embodiments, the length of the tubular extension isbetween 0.1 cm and 10 cm. In preferred embodiments, the length of thetubular extension may be varied so that it can reach lesions (e.g.,tumors, vascular malformations, infections, blood clots) of differentdepths. The tubular extension is not limited to a particular diametermeasurement. In preferred embodiments, the diameter of the tubularextension is at least 5 mm in diameter, at least 10 mm in diameter, andat least 20 mm in diameter. In some embodiments, the diameter of thetubular extension is between 1-2 cm, while in other embodiments, thediameter of the tubular extension is between 0.1 cm and 5 cm. Inparticularly preferred embodiments, the length and diameter measurementsof the tubular extension are such that additional medical instruments(e.g., ablative devices, biopsy devices, navigation devices, aspirationdevices, imaging devices, ultrasound probes, etc.) may be positionedwithin the tubular extension. The diameter of the tubular extension ispreferably kept as small as possible to minimize the amount of bone thatis removed and to minimize the exposure to the environment.

In some embodiments the cannula member may comprise more than onetubular extension allowing for simultaneous passage of additionalmedical instruments (e.g., ultrasound probes, ablative devices, biopsydevices, navigation devices, aspiration devices, imaging devices, etc.).

In preferred embodiments, the attachment member comprises a protrudinglip surrounding the edge of the proximal end. The protruding lip is notlimited to a particular size. In preferred embodiments, the protrudinglip extends outward from the tubular extension a distance between, forexample, 0.1 cm and 2 cm. In other preferred embodiments, the protrudinglip contains at least one attachment hole, wherein the at least oneattachment hole is configured to accept a fastening agent such that uponinsertion of the fastening agent into the attachment hole the device issecured within the bone hole. In still other preferred embodiments, thefastening agent is a threaded fastener.

In some embodiments the cannula member may pivot in relationship to theproximal protruding lip so that the cannula can be inserted at differentangles into the bone hole or the underlying tissue surface. In certainembodiments, a fastening agent at the proximal end can secure thecannula in position in relation to the protruding lip.

In some embodiments the cannula member may slide through the proximalprotruding lip so that length of penetration of the cannula into thetissue or the bone hole can be modified. In some embodiments, theprotruding lip has protruding lip fixtures (e.g., edges, lips, tongues,etc.) allowing additional medical instruments (e.g., ablative devices,biopsy devices, navigation devices, aspiration devices, imaging devices,etc.) to lock onto the tubular extension and prevent undesired movementof the medical instrument.

In certain embodiments, the present invention provides a devicecomprising a cutting and cauterizing member. In preferred embodiments,the cutting and cauterizing member comprises a motor operably connectedto the wire or wires, the wire or wires configured for extension andretraction from the motor, the motor configured to continuously rotatethe wire or wires such that a contacting of the continuously rotatingwire or wires with the tissue results in a cutting of the tissue; and anenergy source operably connected to the wire or wires, the energy sourceconfigured to deliver energy (e.g., laser energy, radio-frequencyenergy, electrical energy) to the wire or wires such that the energy isemitted from the at least one wire, wherein a contacting of the at leastone wire emitting energy with the tissue results in a cauterizing of thetissue.

In preferred embodiments, the energy is electrical energy. In preferredembodiments, any number of wires may be used (e.g., 2, 3, 5, 7, 10 . . .15). In other preferred embodiments, the wire is configured to assumeany desired shape (e.g., circular, elliptical, oval, substantiallycircular, coiled). The wire is not limited to a particular lengthdepending on the depth and size of the lesion (e.g., tumor, vascularmalformation, infection, blood clot, etc.). In preferred embodiments,the length of the wire is at least 0.25 cm in length (e.g., 0.5 cm inlength, 0.75 cm in length, 1 cm in length, 2 cm in length . . . 20 cm inlength). The wire is not limited to a particular diameter measurement.In preferred embodiments, the diameter of the wire is at least 0.05 mm(e.g., 0.075 mm, 0.01 mm 0.05 mm, etc.).

In preferred embodiments, the device is configured for insertion throughthe cannula devices of the present invention. In preferred embodiments,the device is configured to lock into the cannula device so as toprevent it from undesired movement.

In certain embodiments, the present invention provides a devicecomprising a member for aspirating a tissue. In preferred embodiments,the member for aspirating a tissue comprises at least one suction armcomprising an opening end and a closed end, and the suction arm havingtherein a hollow channel running the length of the suction arm throughthe open end. In preferred embodiments, the suction arm has therein atleast one suction opening. In preferred embodiments, the suction arm isconfigured for expansion or retraction into a desired shape. Inpreferred embodiments, the suction member is attached to the at leastone suction arm, the suction member configured to generate a suctionforce through the at least one suction arm, the suction memberconfigured to continuously rotate the at least one suction arm, whereina contacting of the continuously rotating at least one suction arm withthe tissue results in aspiration of at least a portion of the tissuethrough the at least one suction opening. In other preferredembodiments, the suction member has therein at least one suctionopening.

In preferred embodiments, the at least one suction arm comprises atleast two suction arms (e.g., 2, 3, 5, 7, 10 . . . 15 suction arms). Thesuction arm is not limited to a particular length. In preferredembodiments, the length of the at least one suction arm is at least 1 cm(e.g., at least 1.5 cm, at least 2 cm . . . at least 5 cm). In preferredembodiments, the dimensions of the suction arm are configured such thatthe suction arm is capable of expanding into the shape of a circle withat least 1 cm diameter. In preferred embodiments, the diameter of the atleast one suction arm is at least 0.5 cm (e.g., 1 cm, 2 cm . . . 5 cm).In other preferred embodiments, the aspirated tissue is collected in thesuction member.

In preferred embodiments, the tissue is a tumor (e.g., a brain tumor), ahematoma, abscess, or contused brain tissue. In preferred embodiments,the at least one suction opening comprises at least 2 suction openings(e.g., 2, 3, 5, 10, 20, 50 . . . 100 suction arms). In preferredembodiments, the device is configured for insertion through the cannuladevices of the present invention.

In certain embodiments, the present invention provides a devicecomprising a hemostasis promoting member. In preferred embodiments, thehemostasis promoting member comprises a hemostasis member, thehemostasis member configured for inflation and deflation; and anexpansion member attached to the hemostasis member, the expansion memberconfigured to inflate the hemostasis member, wherein upon a contactingof the inflated hemostasis member with the tissue promotes hemostasis ofthe tissue.

In preferred embodiments, the hemostasis member is a balloon. Inpreferred embodiments, the balloon is not limited to a particular typeof material (e.g., rubber, plastic, nylon, or mixture thereof). Inpreferred embodiments, the exterior of the balloon is coated with apharmaceutical agent (e.g., thrombogenic agent, wound healing agent,anti-cancer agent). In preferred embodiments, the diameter of aninflated balloon at least 0.5 cm (e.g., 1 cm, 2 cm . . . 5 cm). Inpreferred embodiments, the length of an inflated balloon is at least 0.5cm (e.g., 1 cm, 2 cm . . . 5 cm). In preferred embodiments, the tissueis a hemorrhaging tissue. In other preferred embodiments, the hemostasismember conforms in shape to a body cavity. In still other preferredembodiments, the expansion member is configured to deflate thehemostasis member. In preferred embodiments, the device is configuredfor insertion through the cannula devices of the present invention. Inpreferred embodiments, the hemostasis member is able to inducehemostasis within a hemorrhaging body cavity (e.g., a hemorrhaging braintumor cavity). In preferred embodiments, the tip of an inflated balloonmay have an opening to allow, for example, injection of solutions orother materials into the cavity. In preferred embodiments, the tip of aninflated balloon may have an opening to allow for aspiration ofsolutions or other materials from the cavity.

In certain embodiments, the present invention provides a devicecomprising a cutting and cauterizing member, an aspiration member, and ahemostasis promoting member. In certain embodiments, the presentinvention provides a device comprising a cutting and cauterizing member,and an aspiration member. In certain embodiments, the present inventionprovides an aspiration member, and a hemostasis promoting member.

In certain embodiments, the present invention provides a cutting andcauterizing member, and a hemostasis promoting member.

In certain embodiments, the present invention provides a systemcomprising an accessory agent positioned within a cannula member. Inpreferred embodiments, the accessory agent is selected from the groupconsisting of a cutting and cauterizing member, an aspiration member,and a hemostasis member.

In certain embodiments, the present invention provides a kit or systemcomprising at least two accessory agents selected from the groupconsisting of a device comprising a cannula member, a device comprisinga cutting and cauterizing member, a device comprising an aspirationmember, and a device comprising a hemostasis member. In preferredembodiments, the kit or system further comprises at least of anadditional accessory agent selected from the group consisting of anablation device, an imaging device, and a pharmaceutical agent. Inpreferred embodiments, the kit or system comprises a device comprising acannula member, and a device comprising a cutting and cauterizingmember. In preferred embodiments, the kit or system comprises a devicecomprising a cannula member, and a device comprising an aspirationmember. In preferred embodiments, the kit or system comprises a devicecomprising a cannula member, and a device comprising a hemostasismember. In preferred embodiments, the kit or system comprises a devicecomprising a cannula member, and a device comprising a cutting andcauterizing member and an aspiration member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, and adevice comprising an aspiration member and a hemostasis member. Inpreferred embodiments, the kit or system comprises a device comprising acannula member, and a device comprising a cutting and cauterizing memberand a hemostasis member. In preferred embodiments, the kit or systemcomprises a device comprising a cannula member, a device comprising acutting and cauterizing member and an aspiration member, and a devicecomprising a hemostasis member. In preferred embodiments, the kit orsystem comprises a device comprising a cannula member, a devicecomprising an aspiration member and a hemostasis member, and a devicecomprising a cutting and cauterizing member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, adevice comprising a cutting and cauterizing member and a hemostasismember, and a device comprising an aspiration member. In preferredembodiments, the kit or system comprises a device comprising a cannulamember, and a device comprising a cutting and cauterizing member, anaspiration member, and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, adevice comprising a cutting and cauterizing member, a device comprisingan aspiration member, and a device comprising a hemostasis member. Inpreferred embodiments, the kit or system comprises a device comprising acannula member, a device comprising a cutting and cauterizing member,and a device comprising an aspiration member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, adevice comprising an aspiration member, and a device comprising ahemostasis member. In preferred embodiments, the kit or system comprisesa device comprising a cutting and cauterizing member and an aspirationmember. In preferred embodiments, the kit or system comprises a devicecomprising an aspiration member and a hemostasis member. In preferredembodiments, the kit or system comprises a device comprising a cuttingand cauterizing member and a hemostasis member. In preferredembodiments, the kit or system comprises a device comprising a cuttingand cauterizing member and an aspiration member, and a device comprisinga hemostasis member. In preferred embodiments, the kit or systemcomprises a device comprising an aspiration member and a hemostasismember, and a device comprising a cutting and cauterizing member. Inpreferred embodiments, the kit or system comprises a device comprising acutting and cauterizing member and a hemostasis member, and a devicecomprising an aspiration member. In preferred embodiments, the kit orsystem comprises a device comprising a cutting and cauterizing member,an aspiration member, and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cutting andcauterizing member, a device comprising an aspiration member, and adevice comprising a hemostasis member. In preferred embodiments, the kitor system comprises a device comprising a cutting and cauterizingmember, and a device comprising an aspiration member. In preferredembodiments, the kit or system comprises a device comprising a cuttingand cauterizing member, and a device comprising a hemostasis member. Inpreferred embodiments, the kit or system comprises a device comprisingan aspiration member, and a device comprising a hemostasis member.

In certain embodiments, the present invention provides a method oftreating a brain tissue mass, comprising a) providing i) a subject witha brain tissue mass; ii) a cannula device secured within a burr holesuch that the cannula device is contacting the brain tissue mass, thecannula device comprising a tubular extension comprising an proximal anddistal ends, the tubular extension having a longitudinal axis and havingtherein a hollow channel parallel to the longitudinal axis, the hollowchannel running the length of the tubular extension through the proximaland distal ends, wherein upon insertion into a bone hole the tubularextension extends beyond the bone hole and into the body cavitysurrounding the bone hole; and an attachment member on the proximal endof the tubular extension, wherein the attachment member comprises anoverhang portion that extends beyond the tubular extension, wherein theoverhang portion engages the surface of said bone thereby securing saidcannula device within said burr hole; and iii) an accessory agent; andb) positioning the accessory agent within the tubular extension of thecannula device such that the accessory agent is contacting the braintissue mass; and c) treating the brain tissue mass with the accessoryagent. In preferred embodiments, the brain tissue mass is a brain tumor.In preferred embodiments, the brain tumor is a deeply seated braintumor. In preferred embodiments, the attachment member is configuredsuch that as the tubular extension is inserted into the bone hole theattachment member engages the outside of the bone hole thereby securingthe device within the bone hole.

In preferred embodiments, the overhang portion has therein a pluralityof holes configured to receive fastening agents. In some embodiments,the holes within the overhang portion have therein threaded fastenerssuch that the threaded fasteners engage the surface of the burr hole.

In some embodiments, the attachment member configured such that as thetubular extension is inserted into the burr hole the attachment memberengages the outside of the bone hole thereby securing the device withinthe bone hole.

In preferred embodiments, the accessory agent is selected from the groupconsisting of an ablation device, an imaging device, a pharmaceuticalagent, a device comprising a cutting and cauterizing member, a devicecomprising an aspiration member, and a device comprising a hemostasispromoting member, a device comprising a cutting and cauterizing memberand an aspiration member, a device comprising an aspiration member and ahemostasis member, a device comprising a cutting and cauterizing memberand a hemostasis member, and a device comprising a cutting andcauterizing member, an aspiration member, and a hemostasis promotingmember.

In certain embodiments, the present invention provides a method oftreating a brain tissue mass, comprising a) providing i) a subject witha brain tissue mass; ii) a surgical device selected from the groupconsisting of a device comprising a cutting and cauterizing member, adevice comprising an aspiration member, a device comprising a hemostasispromoting member, a device comprising a cutting and cauterizing memberand an aspiration member, a device comprising an aspiration member and ahemostasis member, a device comprising a cutting and cauterizing memberand a hemostasis member, and a device comprising a cutting andcauterizing member, an aspiration member, and a hemostasis promotingmember; b) contacting the brain tissue mass with the surgical device;and c) treating the brain tissue mass with the surgical device.

In certain embodiments, the present invention provides a method oftreating a brain tissue mass, comprising a) providing a subject with abrain tissue mass; a device secured within a burr hole of the subject'scranium such that the device is contacting the brain tissue mass, thedevice comprising a cannula member; and a surgical device; and b)positioning the surgical device through the cannula member such that thesurgical device is contacting the brain tissue mass; and c) treating thebrain tissue mass with the surgical device.

In preferred embodiments, the cannula member comprises a tubularextension comprising proximal and distal ends, the tubular extensionhaving a longitudinal axis and having therein a hollow channel parallelto the longitudinal axis, the hollow channel running the length of thetubular extension through the proximal and distal ends. In preferredembodiments, the cannula member comprises an attachment member attachedto the proximal end of the tubular extension, the attachment memberconfigured such that as the cannula device is inserted into a bone holethe attachment member engages the surface of the bone thereby securingthe cannula device within the burr hole.

In preferred embodiments, the brain tissue mass is a brain tumor. Inpreferred embodiments, the surgical device is selected from the groupconsisting of a device comprising a cutting and cauterizing member, adevice comprising an aspiration member, and a device comprising ahemostasis promoting member. In some embodiments, the surgical device isthe device comprising a cutting and cauterizing member, and the treatingstep comprises cutting and cauterizing the brain tissue mass with thedevice comprising a cutting and cauterizing member. In preferredembodiments, the surgical device is the device comprising an aspirationmember, and the treating step comprises suctioning at least a portion ofthe brain tissue mass with the aspiration member. In preferredembodiments, the surgical device is the device comprising a hemostasispromoting member, and the treating step comprises inducing hemostasis onat least a portion of the subject's brain tissue with the devicecomprising a hemostasis promoting member.

In certain embodiments, the present invention provides a kit comprisinga) a device comprising a cannula member, the cannula member comprising atubular extension comprising proximal and distal ends, the tubularextension having a longitudinal axis and having therein a hollow channelparallel to the longitudinal axis, the hollow channel running the lengthof the tubular extension through the proximal and distal ends, thetubular extension configured such that upon insertion into a bone thetubular extension extends into the body cavity surrounding the bonehole; and an attachment member attached to the proximal end of thetubular extension, the attachment member configured such that as thecannula device is inserted into a bone hole the attachment memberengages the surface of the bone thereby securing the cannula devicewithin the bone hole; and b) at least one surgical device selected fromthe group consisting of a device comprising a cutting and cauterizingmember, a device comprising an aspiration member, and a devicecomprising a hemostasis promoting member.

In preferred embodiments, the at least one surgical device is at least 2or more of the surgical devices. In preferred embodiments, the at leastone surgical device is at least 3 or more of the surgical devices. Inpreferred embodiments, the hemostasis promoting member comprises athrombogenic agent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a cannula device embodiment of the presentinvention.

FIG. 2 depicts a cross-sectional side view of a cannula devicepositioned within a burr hole.

FIG. 3 depicts a cannula device inserted through the brain and onto abrain tumor.

FIG. 4 shows a schematic diagram of a cutting and cauterizing deviceembodiment of the present invention.

FIGS. 5A-B show side views of a cutting and cauterizing devicepositioned within a cannula device secured within a burr hole.

FIGS. 6A-C show exemplary shapes the cutting and cauterizing wire mayassume.

FIGS. 7A-B show side views of an aspiration device embodiment of thepresent invention.

FIGS. 8A-B show an aspiration device positioned within a cannula device.

FIGS. 9A-C show an aspiration device positioned within a cannula devicesecured within a burr hole.

FIG. 10 shows a side view of a hemostasis promoting device embodiment ofthe present invention.

FIG. 11 shows a hemostasis promoting device positioned within a cannuladevice secured within a burr hole.

FIG. 12 shows pictorially one embodiment of the steps that can be takento treat a hematoma or tumor using a probe device and relatedcomponents.

FIG. 13 shows one embodiment of the systems of the present inventionincluding a loop/wire containing probe, an RF generator component, anirrigation supply component, and a controller component.

FIG. 14 shows one embodiment of the loop/wire containing probe device ofthe present invention.

FIG. 15 shows one embodiment of the proximal end of a probe device.

FIG. 16 shows one embodiment of the distal end of a probe device.

FIG. 17 shows an exemplary side view of probe device illustrating theadjustable loop size. In certain embodiments, the expanded diameter ofthe loops is set by the probe extension past the distal end of thecannula. In certain embodiments, the probe sleeve's external threadinginterlocks with the cannula threading to set the diameter of the loops.

FIG. 18A shows one embodiment of a probe device with 4 loops in theunexpanded position (straight arrows), while FIG. 18B shows the 4 loopsin the expanded position. The curved arrows in the figure show elongatedslots (evacuation ports) in the central stem. The evacuation ports, viathe central stem, may be linked to vacuum and/or irrigation sources.

DEFINITIONS

To facilitate an understanding of the invention, a number of terms aredefined below.

As used herein, the term “bone hole” refers to a surgically insertedhole through a bone (e.g., cranium, mandible, cervical vertebrae,clavicle, scapula, sternum, ribs, humerus, thoracic vertebrae, lumbarvertebrae, ulna, radius, pelvis, carpals, phalanges, sacrum,metacarpals, femur, patella, tibia, fibula, tarsals, metatarsals).

As used herein, the term “burr hole” refers to a surgically insertedhole through the cranium. Generally, a “burr hole” is utilized duringneurosurgical procedures.

As used herein, the term “subject” refers to any living entity. Examplesof subject include, but are not limited to, cats, dogs, mice, primates,humans, birds, and fish.

As used herein, the term “tissue” refers to a part of a group of cellswithin a subject's body. An example of a tissue is a brain tumor.

As used herein, the term “tumor” refers to an abnormal mass of tissuethat results from, for example, excessive cell division. A tumor mayalso represent other mass-occupying lesions such as hematomas, bloodclots, or infections.

As used herein, the term “brain tumor” refers to a tumor located withina subject's brain. Examples of brain tumors include, but are not limitedto, astrocytoma tumors, glioma tumors, atypical teratoid I rhabdoidtumors, brain stem gliomas, choroid plexus tumors, craniopharyngiomas,ependymoma tumors, ganglioglioma tumors, germ cell tumors, gliomatosiscerbri tumors, infant brain tumors, medulloblastoma tumors,oligodendroglioma tumors, and optic pathway tumors. Brain tumors can belocated near a subject's cranium surface (e.g., within 2 cm of thesubject's cranium surface) or located in a deeply seated region of thebrain (e.g., at least 2 cm away from the subject's cranium surface).

As used herein, the term “deeply seated brain tumor” refers to braintumors located in difficult to reach areas of the brain (e.g., locatedat least 2 cm away from the subject's cranium surface). Examples ofdeeply seated brain tumors include, but are not limited to, brain tumorslocated in the brain stem, brain tumors located in the thalamus, braintumors located in the motor area, and brain tumors located in the deepareas of gray matter.

As used herein, the term “resection” refers to excision of a portion orall of a tissue structure.

As used herein, the term “biopsy” refers to a procedure that involvesobtaining a tissue specimen to establish a precise diagnosis. Biopsiescan be accomplished, for example, with a biopsy needle or by an opensurgical incision.

As used herein, the term “brain cancer” refers to forms to cancerlocated within a subject's brain. Examples of brain cancer include, butare not limited to, childhood brain stem glioma, childhood cerebellarastrocytoma, childhood cerebral astrocytoma/malignant glioma, childhoodependymoma, childhood medulloblastoma, childhood supratentorialprimitive neuroectodermal tumors and pineoblastoma, and visual pathwayand hypothalamic glioma.

As used herein, the term “inflexible” in reference to a tubuleextension, refers to a tubule extension that is rigid such that it isresistant to bending about its longitudinal axis. A tubule extension isconsidered inflexible if it cannot be bent about its longitudinal axisunless such force is applied that causes a permanent bend in the tubuleextension.

DETAILED DESCRIPTION

The present invention relates to surgical devices and related methods ofuse. In particular, the present invention relates to surgical devicesused for contacting and treating brain tissue (e.g., brain tumors).FIGS. 1-11 illustrate various preferred embodiments of the surgicaldevices and related methods thereof. The present invention is notlimited to these particular embodiments.

The illustrated and preferred embodiments describe the devices of thepresent invention in terms of neurosurgical applications (e.g., braintumor resection, brain tumor biopsy, brain tumor imaging, brain hematomaevacuation, decompression of contused or damage brain). However, itshould be appreciated that the devices are not limited to neurosurgicalapplications. Indeed, the devices of the present invention haveapplication in any procedure requiring access to a body cavity through abone structure (e.g., spinal surgery, bone marrow applications, livertumor surgery, etc.).

Cannula Device

FIG. 1 shows a side view of a cannula device 100 embodiment of thepresent invention. The cannula device 100 is not limited to a particularmaterial composition (e.g., synthetic rubber, titanium, biocompatibleplastic, polyacetal, elastomeric material, polyurethane, polyethylene,stainless steel, metal, or mixture thereof). In preferred embodiments,the material composition of the cannula device 100 comprises polyacetal.

In preferred embodiments, the cannula device 100 is configured to engageand attach within a bone hole (e.g., a burr hole) (described in moredetail below). In preferred embodiments, the cannula device 100 isconfigured to provide a passage from the outside of a bone hole to aninterior body cavity (e.g., a deeply seated brain tumor) (described inmore detail below).

Still referring to FIG. 1, in some embodiments, the cannula device 100generally comprises a tubular extension 110 with a tubular extensionproximal end 121 a tubularextension distal end 122, a tubular extensionexterior surface 130, and a tubular extension longitudinal axis 140. Inpreferred embodiments, the tubular extension 110 has therein a tubularextension hollow channel 150 running the length of the tubular extension110 through the two tubular extension proximal and distal ends 121 and122. The tubular extension 110 is not limited to a particular shape(e.g., spherical, oval, conical). In preferred embodiments, the shape ofthe tubular extension 110 is cylindrical. In some preferred embodiments,the tubular extension 110 has an endoscopic camera positioned on thetubular extension distal end 122 (see, e.g., Pediatric Endoscope System,Richard Wolf Neuroendoscopy; herein incorporated by reference in itsentirety). In some preferred embodiments, the tubular extension 110 hasa navigation system (see, e.g., Medtronic Neurosurgery navigationproducts including, but not limited to, StealthStation TREON plusMedtronic Navigational System, StealthStation TRIA plus MedtronicNavigational System, and StealthStation AXIEM Electromagnetic MedtronicNavigational System) positioned on the tubular extension proximal end121 facilitating accurate insertion of the cannula device 100 into abody cavity.

Still referring, in preferred embodiments, the tubular extension 110 hastherein a removable stylet. The cannula member is not limited to aparticular type, size, or shape of stylet. In preferred embodiments, thestylet assists in navigating the cannula device 100 through the brain.In preferred embodiments, the stylet is a rigid metal shaft with drillor screw type structures and a robust (e.g., hardened) end (e.g.,pointed end, curved end). Other suitable stylet configurations aredescribed in, for example, U.S. Pat. No. 6,033,411 and U.S. PatentApplication Publication No. 2002-0188300, each of which is hereinincorporated by reference in their entireties. In preferred embodiments,the stylet is removed after positioning of the cannula device 100 withinthe brain.

Still referring to FIG. 1, the tubular extension 110 is not limited to aparticular length. In preferred embodiments, the length of the tubularextension 110 is at least 2 cm, at least 5 cm in length, and at least 10cm in length. In preferred embodiments, the length of the tubularextension 110 may be varied so that it can reach lesions (e.g., tumors,vascular malformations, infections, blood clots) of different depths.The tubular extension 110 is not limited to a particular diametermeasurement. In preferred embodiments, the diameter of the tubularextension 110 is at least 5 mm in diameter, at least 10 mm in diameter,and at least 20 mm in diameter. In preferred embodiments, the cannuladevices 100 (e.g., designed for neurosurgical procedures) may range insize from, for example, 0.1 to 10 cm in length and 0.1 to 5 cm indiameter. In certain embodiments, the size dimensions for cannuladevices 100 (e.g., designed for neurosurgical applications) ranges from1 to 5 cm in length and 1 to 2 cm in diameter. In particularly preferredembodiments, the length and diameter measurements of the tubularextension 110 are such that additional medical instruments (e.g.,ablative devices, biopsy devices, navigation devices, aspirationdevices, imaging devices, etc.) may be positioned within the tubularextension 110. The diameter of the tubular extension 110 is preferablykept as small as possible to minimize the amount of bone that is removedand to minimize the exposure to the environment. In certain embodiments,the cannula device 100 may comprise of two or more hollow channels 150such that different medical devices can be simultaneously be positionedwithin the tubular extension 110.

Still referring to FIG. 1, in preferred embodiments, as a cannula device100 is positioned within a bone hole (e.g., burr hole), the tubularextension 110 fits within the bone hole such that the tubular extensionexterior surface 130 engages both the interior sides of the bone holeand the interior body cavity situated beyond the bone hole (e.g., thebrain) (described in more detail below). In preferred embodiments, thetubular extension 110 is flexible such that upon insertion into a bodycavity (e.g., brain), the tubular extension may assume a shapeconsistent with the body cavity. In other embodiments, the tubularextension 110 is inflexible. In preferred embodiments, the cannuladevice 100 may be inserted at any angle with respect to the bone hole(e.g., 90, 80, 70, 60, 50, 40, 30, 20, 10, 1 degree angle).

Still referring to FIG. 1, in preferred embodiments, the cannula device100 comprises an attachment member 160 connected to the tubularextension proximal end 121. The attachment member 160 is not limited toa particular position in relation to the tubular extension proximal end121. In certain embodiments, the attachment member 160 extends outwardfrom the tubular extension proximal end 121 at any desired angle (e.g.,0 to 180 degrees). In preferred embodiments, the attachment member 160extends outward from the tubular extension proximal end 121 atapproximately a 90° angle. The attachment member 160 is not limited to aparticular shape (e.g., circular, oval, tabular, triangular, square,diagonal, rectangular, etc.). In preferred embodiments, the shape of theattachment member 160 is a circular protruding lip. The attachmentmember 160 is not limited to a particular extension length. In preferredembodiments, the extension length of the attachment member 160 is atleast 0.1 cm (e.g., at least 0.5 cm, 1 cm . . . 2 cm). In someembodiments, the attachment member 160 has protruding lip fixtures(e.g., edges, lips, tongues, etc.) allowing additional medicalinstruments (e.g., surgical catheters) to lock onto the cannula device100 and prevent undesired movement of the medical instrument.

In some embodiments, the attachment member 160 has protruding lipfixtures (e.g., edges, lips, tongues, etc.) allowing framelessstereotactic navigation systems such as StealthStation (MedtronicNavigation, Colorado) or BrainLAB Vector Vision (Germany) to lock ontothe cannula device 100. Attachment of the navigation system will allowfor planning of surgical instrument placement and predict surgicalinstrument positioning before being passed through the cannula.

Still referring to FIG. 1, in preferred embodiments, as a cannula device100 is positioned within a bone hole (e.g., burr hole), the attachmentmember 160 engages and attaches onto the top surface of the bone therebysecuring the cannula device 100 within the bone (described in moredetail below). In some embodiments, the attachment member 160 attachesonto the top surface of a bone with an adhesive agent (e.g., fibringlue, cranioplastic cement). In preferred embodiments, the attachmentmember 160 attaches onto the top surface of a bone with fastening agents(e.g., nails, threaded fasteners).

Still referring to FIG. 1, the attachment member 160 has therein atleast one attachment hole 170. In preferred embodiments, the attachmentholes 170 are configured to receive threaded fasteners (e.g., screwssuch as bone screws). In preferred embodiments, as a cannula device 100is positioned within a bone hole (e.g., burr hole), threaded fastenersare inserted into the attachment holes 170 such that the cannula device100 is secured into a fixed position within the bone hole. The area ofthe attachment member that extends beyond the tubule extension proximalend 121 is referred to as the overhang portion 175 of the attachmentmember. As shown in FIG. 1, the attachment holes 170 are located in thisoverhang portion 175 of attachment member 160. In some preferredembodiments, the shape of the attachment member 160 is tabular such thatthe overhang portion 175 only encompasses the area surrounding theattachment holes 170.

In other embodiments, the overhang portion extends all the way around,or nearly all the way around, the proximal end of the tubular extension.

Referring again to FIG. 1, the attachment member 160 is not limited to aparticular manner of connection with the tubular extension proximal end121. In some certain embodiments, the attachment member 160 is rigidlyconnected to the tubular extension proximal end 121 at a predeterminedangle (e.g., 0 to 180 degrees) in relation to the tubular extensionproximal end 121. In such embodiments, as the cannula device 100 ispositioned within a bone hole (e.g., a burr hole) the angle of theattachment member 160 in relation to the tubular extension 110 remainsfixed. In other certain embodiments, the attachment member 160 isconnected to the tubular extension proximal end 121 in a flexible manner(e.g., via a movable hinge or other flexible component) such that theattachment member is able to assume any desired angle in relation to thetubular extension proximal end 121 (e.g., 0 to 250 degrees). In suchembodiments, as a cannula 100 is positioned within a bone hole (e.g.,burr hole) the angle of the attachment member 160 in relation to thetubular extension 110 may be adjusted to a desired angle (e.g., uponsecuring of the attachment member 160 with the bone hole, the tubularextension 110 may be adjusted to any desired angle). In other certainembodiments, the attachment member 160 is connected to the tubularextension proximal end 121 in a loose manner (e.g., via a movable hinge)such that the tubular extension 110 can slide in relation to theattachment member 160.

Still referring to FIG. 1, in some embodiments, the attachment member160 has protruding lip fixtures (e.g., edges, lips, tongues, etc.)allowing additional medical instruments (e.g., ablative devices, biopsydevices, navigation devices, aspiration devices, imaging devices, etc.)to lock onto the cannula device 100 and prevent undesired movement ofthe medical instrument.

FIG. 2 depicts a cross-sectional side view of a cannula device 100positioned within a burr hole 180. As shown, the cannula device 100 hasa tubular extension 120 with a tubular extension proximal end 121, atubular extension distal end 122, a tubular extension exterior surface130, and a longitudinal axis 140. The tubular extension 110 has thereina tubular extension hollow channel 150 running the length of the tubularextension 110 through the tubular extension proximal end 121 and thetubular extension distal end 122. Additionally, the cannula device 100has an attachment member 160 with four attachment holes 170 positionedwithin the overhang portion 175. Threaded fasteners 190 are positionedwithin the attachment holes 170 and the cranium 200 such that thecannula device 100 is secured within the burr hole 180. In addition, theoverhang portion 175 is shown extending beyond the tubular extensionproximal end 121.

Still referring to FIG. 2, the tubular extension exterior surface 130 isshown engaging the interior sides of the burr hole 180 and the brain210. As such, in preferred embodiments, the cannula device 100 providesa secure passageway between the outside of the burr hole 180 to aninterior region of the brain 210 (e.g., brain stem). The passagewayprovided by the cannula device 100 provides access to the brain 210 forsurgical purposes (e.g., brain tumor biopsy, brain tumor resection,brain tumor imaging, brain tumor treatment, evacuation of brainhematoma, removal of damaged and contused brain tissue, removal of braininfections, etc.) (described in more detail below).

FIG. 3 depicts a cannula device 100 inserted through the brain 210 andonto a region of the brain containing a brain tumor 220. FIG. 3demonstrates one of the advantages the cannula device 100 provides in aneurosurgical setting. In particular, the cannula device permits aneurosurgeon to obtain a direct opening or passageway from a burr hole,through the brain pia, to the surface of a deeply seated brain tumor.The passageway can be used for many surgical purposes, including but notlimited to, administration of medications, and insertion of surgicalinstruments for treatment purposes (e.g., tumor cauterization, tumoraspiration, tumor biopsy).

Cutting and Cauterizing Device

FIG. 4 shows a schematic diagram of a cutting and cauterizing device 300embodiment of the present invention. In preferred embodiments, thecutting and cauterizing device 300 is configured to cut a tissue (e.g.,brain tumor) and cauterize a tissue (e.g., brain tumor) (described inmore detail below).

Still referring to FIG. 4, the cutting and cauterizing device 300generally comprises a cutting and cauterizing device motor 310 connectedto at least one cutting and cauterizing device wire 320. In preferredembodiments, the cutting and cauterizing device wire 320 may assume anydesired shape (e.g., a linear shape, a curvilinear shape, a circularshape, a zig-zagged shape). The cutting and cauterizing device wire 320is not limited to a particular length. In preferred embodiments, thelength of the cutting and cauterizing device wire 320 is at least 0.25cm in length (e.g., 0.5 cm in length, 0.75 cm in length, 1 cm in length,2 cm in length . . . 20 cm in length). The cutting and cauterizingdevice wire 320 is not limited to a particular diameter measurement. Inpreferred embodiments, the diameter of the cutting and cauterizingdevice wire 320 is at least 0.05 mm (e.g., 0.075 mm, 0.01 mm . . . 0.05mm, etc.). In preferred embodiments, the length, diameter, and shape ofthe cutting and cauterizing device wire 320 are such that the cuttingand cauterizing device wire 320 is able to wrap around a desired tissue(e.g., brain tumor). In particularly preferred embodiments, the cuttingand cauterizing device wire 320 is configured to cut through a tissueand cauterize the tissue (described in more detail below).

Still referring to FIG. 4, in preferred embodiments, the cutting andcauterizing device motor 310 is configured to expand and retract thecutting and cauterizing device wire 320. The cutting and cauterizingdevice motor 310 is not limited to a particular type or size of motor.In preferred embodiments, the size of the cutting and cauterizing devicemotor 310 is able to fit (e.g., in an expanded or unexpanded form)within the cannula device described above. In preferred embodiments, thecutting and cauterizing device motor 310 is configured to continuouslyrotate the cutting and cauterizing device wire 320. The cutting andcauterizing device motor 310 is able to continuously rotate the cuttingand cauterizing device wire 320 at any desired rotational speed (e.g.,at least 0.1 rotations per second, 1 rotation per second, 10 rotationsper second, 100 rotations per second, 1000 rotations per second). Inpreferred embodiments, a continuously rotating cutting and cauterizingdevice wire 320 is able to cut a tissue (e.g., a brain tumor).

Still referring to FIG. 4, the cutting and cauterizing device 300comprises a cutting and cauterizing device energy source 330. Thecutting and cauterizing device energy source 330 is not limited to aparticular type of energy (e.g., electric, radiation, laser). Inpreferred embodiments, the energy source of the cutting and cauterizingdevice energy source 330 is electric energy. In preferred embodiments,the cutting and cauterizing device energy source 330 is configured todeliver energy (e.g., electric current energy) to the cutting andcauterizing device wire 320. In preferred embodiments, the cutting andcauterizing device electric energy wire 320 is configured to emit energyreceived from the cutting and cauterizing device energy source 330. Inparticularly preferred embodiments, the emission of energy (e.g.,electric energy) from the cutting and cauterizing device wire 320cauterizes a tissue (e.g., a brain tumor).

FIGS. 5A-B show a side view of a cutting and cauterizing device 300secured within a burr hole 180. As shown, the cutting and cauterizingdevice 300 has a cutting and cauterizing device wire 320. The cuttingand cauterizing device wire 320 is shown extending beyond the terminusof the cannula device 100 and onto a brain tumor 220. The cutting andcauterizing device wire 320 is shown assuming the shape of the braintumor 220. In preferred embodiments, continuous rotation of the cuttingand cauterizing device wire 320 allows the cutting of the brain tumor.In preferred embodiments, emission of electric energy through thecutting and cauterizing device wire 320 allows cauterization of thebrain tumor.

Still referring to FIGS. 5A-B, FIG. 5A shows the cutting and cauterizingdevice wire 320 within the brain tumor 220. The cutting and cauterizingdevice 300 is shown rotating. FIG. 5A shows the cutting and cauterizingdevice wire 320 expanded and taking a circular shape just up to the edgeof the tumor 220. FIG. 5B shows a devascularized tumor 220 after thecutting and cauterizing device 300 is removed.

FIGS. 6A-C show exemplary shapes the cutting and cauterizing wire 320may assume.

FIG. 6A displays the cutting and cauterizing device wire 320 in a linearshape.FIG. 6B displays the cutting and cauterizing device wire 320 in an ovalshape (see, e.g., the arrows indicating the expansion of the cutting andcauterizing device wire 320).FIG. 6C displays the cutting and cauterizing device wire 320 in acircular shape. As such, the cutting and cauterizing device 300 providesa neurosurgeon with a powerful cutting and cauterizing instrumentcapable of assuming various shapes depending on the particular shape andsize of the tissue (e.g., brain tumor). Use of the cannula device andthe cutting and cauterizing device together provides a direct passagewayand treatment approach for deeply seated tumors (e.g., brain stemtumors).

Aspiration Device

FIGS. 7A and 7B show side views of an aspiration device 400 embodimentof the present invention. The aspiration device 400 generally comprisesat least one aspiration device suction arm 410 and an aspiration devicesuction member 420. The aspiration device 400 is not limited to aparticular size. In preferred embodiments, the aspiration device 400 isable to fit within the cannula devices of the present invention. Inpreferred embodiments, the aspiration device 400 is configured toaspirate a fragmented (e.g., cut) tissue (e.g., brain tumor) (describedin more detail below).

Still referring to FIGS. 7A and 7B, the aspiration device suction arm410 has an aspiration device suction arm open end 430, an aspirationdevice suction arm closed end 440, and has therein an aspiration devicesuction arm hollow channel 460. In preferred embodiments, the length ofthe aspiration device suction arm 410 is at least 1 cm (e.g., at least1.5 cm, at least 2 cm . . . at least 3 cm). In preferred embodiments,the diameter of the aspiration device suction arm 410 is at least 0.5 cm(e.g., 1 cm, 2 cm . . . 5 cm). The aspiration device suction arm 410 isnot limited to a particular shape (e.g., linear, curvilinear,zig-zagged, oval, circular). In preferred embodiments, the aspirationdevice suction arm 410 is configured to assume any desired shape. Inpreferred embodiments, the dimensions of the aspiration device suctionarm 410 are configured such that the aspiration device suction arm 410is capable of expanding into the shape of a circle with at least a 1 cmdiameter. In preferred embodiments, the aspiration device suction arm410 is configured to expand or contract in shape. In preferredembodiments, expansion or contraction of the aspiration device suctionarm 410 permits the contacting of a tissue (e.g., brain tumor) with theaspiration device 400.

Still referring to FIGS. 7A and 7B, the aspiration device 400 hasaspiration device suction aspiration device suction arm 410 is notlimited to a particular shape (e.g., linear, curvilinear, zig-zagged,oval, circular). In preferred embodiments, the aspiration device suctionarm 410 is configured to assume any desired shape. In preferredembodiments, the dimensions of the aspiration device suction arm 410 areconfigured such that the aspiration device suction arm 410 is capable ofexpanding into the shape of a circle with at least a 1 cm diameter. Inpreferred embodiments, the aspiration device suction arm 410 isconfigured to expand or contract in shape. In preferred embodiments,expansion or contraction of the aspiration device suction arm 410permits the contacting of a tissue 20 (e.g., brain tumor) with theaspiration device 400.

Still referring to FIGS. 7A and 7B, the aspiration device 400 hasaspiration device suction openings 450. The aspiration device suctionopening 450 is not limited to a particular location within theaspiration device 400. In some embodiments, the aspiration devicesuction opening 450 is positioned along the aspiration device suctionarm 410 (as shown in FIG. 7A). In preferred embodiments, positioning ofan aspiration device suction opening 450 along the aspiration devicesuction arm 410 permits, for example, the contacting of a tissue withthe aspiration device suction arm 410 such that the tissue is aspiratedthrough the aspiration device suction opening 450. In other embodiments,the aspiration device suction opening 450 is positioned within theaspiration device suction member 420 (as shown in FIG. 7B). In preferredembodiments, positioning of an aspiration device suction opening 450along the aspiration device suction member 420 permits, for example, thecontacting of a tissue with the aspiration device suction arm 410 suchthat the tissue is drawn toward the aspiration device suction member 420where the tissue is aspirated through the aspiration device suctionopening 450.

Still referring to FIGS. 7A and 7B, the aspiration device 400 is notlimited to a particular number of aspiration device suction openings450. In preferred embodiments, the aspiration device 400 has at least 1aspiration device suction opening 450. The aspiration device suctionopening 450 is not limited to a particular size. In preferredembodiments, the size of the aspiration device suction opening 450 issuch that fragmented tissues are able to flow into the aspiration devicesuction opening 450. The aspiration device suction opening 450 is notlimited to a particular shape (e.g., rectangular, oval, circular,square, triangular, zig-zagged). In preferred embodiments, the shape ofthe aspiration device suction opening 450 is oval and/or rectangular.

Still referring to FIGS. 7A and 7B, the aspiration device suction member420 is configured to generate a suction force through the aspirationdevice suction opening 450. Additionally, the aspiration device suctionmember 420 is configured to continuously rotate the aspiration devicesuction arm 410. The aspiration device suction member 420 is not limitedto a particular method of operation (e.g., a suction motor, a rotationalmotor). The aspiration device suction member 420 is configured toprovide any desired amount of suction force through the aspirationdevice suction opening 450. In preferred embodiments, the amount ofsuction force provided by the aspiration device suction member 420 issufficient to aspirate a fragmented tissue (e.g., fragmented braintumor).

In preferred embodiments, the aspiration device suction member 420 isconfigured to continuously rotate the aspiration device suction arm 410at any desired rotational speed (e.g., at least 0.1 rotations persecond, 1 rotation per second, 10 rotations per second, 100 rotationsper second, 1000 rotations per second). In preferred embodiments, theaspiration device suction member 420 is configured to continuouslyrotate the aspiration device suction arm 410 while simultaneouslyapplying a suction force through the aspiration device suction opening450.

FIGS. 8A and 8B show an aspiration device 400 positioned within acannula device 100. As shown, the aspiration device 400 has anaspiration device suction member 420 and an aspiration device suctionarm 410 having therein aspiration device suction openings 450. In FIG.8A, the aspiration device suction openings 450 are positioned along theinterior of the aspiration device suction arm 410. In FIG. 8B, theaspiration device suction openings 450 are positioned along the exteriorof the aspiration device suction arm 410. As shown in FIGS. 8A and 8B,the aspiration device 400 is positioned within the cannula device 100such that the aspiration device suction member 420 engages the walls ofthe cannula device 100, and the aspiration device suction arm 410extends beyond the terminus of the cannula device 100. The shape of theaspiration device suction arm 410 is circular (see, e.g., the arrowsindicating the aspiration device suction arm 410 is configured to assumea circular shape).

FIG. 9 shows an aspiration device 400 positioned within a cannula device100 secured within a burr hole 180. As shown, the aspiration device 400has an aspiration device suction member 420 and an aspiration devicesuction arm 410 having therein aspiration device suction openings 450.As shown, the aspiration device 400 is positioned within the cannuladevice 100 such that the aspiration device suction member 420 engagesthe walls of the cannula device 100, and the aspiration device suctionarm 410 extends beyond the terminus of the cannula 100. The shape of theaspiration device suction arm 410 is circular. In preferred embodiments,the aspiration device 400 is configured such that continuous rotation ofthe aspiration device suction arm 410 while simultaneously providing asuction force through the aspiration device suction arm 410 permits theaspiration of tissue from a body cavity (e.g., a fragmented brain tumorcavity).

Still referring to FIG. 9, FIG. 9A shows the aspiration device suctionarm 410 positioned around a circumference creating an interior space,which may contain a brain tumor. The arrows indicate the suction forceprovided through the aspiration device suction openings 450. FIG. 9Bshows the aspiration device suction arm 410 rotating around the interiorspace (e.g., brain tumor, see, e.g., the rotational arrow) whileapplying a suction force through the aspiration device suction openings450. FIG. 9B also shows a wire 320 for cutting brain tissue. FIG. 9Cshows an aspirated cavity of a brain tumor 220 following application ofthe aspiration device 400. Use of the cannula devices of the presentinvention and the aspiration device together provides a directpassageway and aspiration approach for deeply seated tumors (e.g.,thalamus tumors) or hematomas.

Hemostasis Promoting Device

FIG. 10 shows a side view of a hemostasis promoting device 500embodiment of the present invention. The hemostasis promoting device 500generally comprises a hemostasis member 510 and a expansion member 520.The hemostasis promoting device 500 is not limited to a particular size.In preferred embodiments, the hemostasis promoting device 500 is able tofit within the cannula devise described above. In preferred embodiments,the hemostasis promoting device 500 is able to induce hemostasis withina hemorrhaging body cavity (e.g., a hemorrhaging brain tumor cavity)(described in more detail below).

Still referring to FIG. 10, the hemostasis member 510 is configured forinflation and deflation. The hemostasis member 510 is not limited to aparticular material composition (e.g., rubber, plastic, nylon, ormixture thereof). In preferred embodiments, the material composition ofthe hemostasis member 510 is synthetic rubber. The hemostasis member 510is not limited to a particular size. The hemostasis member 510 is notlimited to a particular shape. In preferred embodiments, the deflatedshape of the hemostasis member 510 is shriveled. In preferredembodiments, the inflated shape of the hemostasis member 510 is circular(e.g., inflated balloon shape). In particularly preferred embodiments,upon insertion into a body cavity, the inflated shape of the hemostasismember 510 matches the shape of the body cavity.

Still referring to FIG. 10, the hemostasis member 510 is configured toinduce hemostasis upon a hemorrhaging body cavity. The hemostasis member510 is not limited to a particular method of promoting hemostasis. Insome preferred embodiments, the hemostasis member 510 provides directpressure onto the body cavity thereby promoting hemostasis. In otherpreferred embodiments, the exterior surface of the hemostasis member 510contains a hemostasis promoting agent. The present invention is notlimited to particular hemostasis promoting agents. In preferredembodiments, hemostasis promoting agent is a thrombogenic agent.

Still referring to FIG. 10, the expansion member 520 is configured toinflate and deflate the hemostasis member 510. The expansion member 520is not limited to a particular method of inflating and deflating thehemostasis member 510. In some preferred embodiments, the expansionmember 520 inflates the hemostasis member 510 by filling it with agaseous substance (e.g., air). In some preferred embodiments, theexpansion member 520 inflates the hemostasis member 510 with a liquidsubstance (e.g., water, radiolabeled liquid). In preferred embodiments,the expansion member 510 deflates the hemostasis member 510 by removingthe inflation agent (e.g., gaseous substance, liquid substance). Inparticularly preferred embodiments, the expansion member 520 isconfigured to inflate or deflate the hemostasis member 510 such that itfits a body cavity (e.g., a brain tumor cavity). In preferredembodiments, the expansion membrane has an internal cannula with an opendistal end. This opening can allow for injection of solutions such ashemostatic agents or other materials into the cavity. In preferredembodiments, the tip of the hemostasis member 510 may have an opening toallow for aspiration of solutions or other materials from the cavity.

FIG. 11 shows a hemostasis promoting device 500 positioned within acannula device 100 secured within a burr hole 180. As shown, thehemostasis promoting device 500 has an hemostasis member 510 and aexpansion member 520. The hemostasis promoting device 520 is positionedwithin the cannula device 100 such that the expansion member 520 engagesthe walls of the cannula device 100, and the hemostasis member 510extends beyond the terminus of the cannula device 100. The hemostasismember 510 is shown in an inflated shape such that it has assumed theshape of the body cavity. The hemostasis member 510 is configured suchthat hemostasis is induced upon contact with the cavity of the braintumor 220. Use of the cannula devices of the present invention and thehemostasis promoting device together provides a direct passageway andhemostasis approach for deeply seated tumors (e.g., thalamus tumors).

Wire Containing Probe Devices and Exemplary Methods

The present invention provides wire (loop) containing probe devices andmethods for employing such devices. The instrument probe allows, forexample, for removal of intracerebral hematomas, and brain tumors,through a small burr hole. The probe instrument described below may beinserted through a cannula which is introduced up to the surface of thelesion using currently available navigation systems. The probe device isthen passed through this port to disconnect, cauterize, fragment and/oraspirate the hematoma (or tumor tissue).

One exemplary embodiment employing the probe (described in more detailbelow) is depicted in FIG. 12 and is described as follows:

-   -   1) A standard burr hole 680 measuring 7-14 mm in diameter is        created. The mounting mechanism fixture 660 is secured in place        to the skull 710. The mounting system shown in FIG. 12 is        exemplary. In certain embodiments, the mounting mechanism is        designed based on specifics of the probe design and navigation        system, and will pivot and can even be secured with a robotic        arm.    -   2) A Cannula 600, that will provide access to the brain mass and        allow for passage of subsequent instruments, is inserted next.        This cannula (e.g., diameter: 0.5-1 cm; length 2-5 cm) may have        a stylet which will be removed after insertion and may be made        of advanced engineered polymers such as PEEK known for its high        strength and bio-compatibility. A Cannula can be inserted using        image guidance techniques (such as Stealth or BrainLab) up to        the edge of the mass and tubular extension 610 will act as        channel for passage of subsequent devices.    -   3) The probe 670 (with cutting wires 674) is introduced next        through the cannula and is used for separation, fragmentation,        and aspiration of the mass 709 (i.e., tumor, lesion or hematoma,        for example) from surrounding brain tissue. The tip 676 of the        probe extends through the lesion to the other surface of the        lesion before locking into place. The probe has a central stem        620 containing a rotating shaft (FIGS. 17 and 18) that has        multiple wires (loops/prongs 674) that will expand and conform        into a circle (or other shapes). These conductive (metallic)        wires can connect to a radio-frequency (RF) source (FIG. 13) and        can extend within the hematoma, or beyond the edge of the tumor,        to allow for disconnection of the mass from surrounding hematoma        or gliotic margin (in case of tumors) using RF energy.    -   4) The Probe shaft 620 is retracted and a balloon 510 is        introduced next. The balloon is used for hemostasis and        tamponade of small bleeding vessel. This balloon-type device is        inserted through the cannula and inflated to the appropriate        volume to expand and completely fill the cavity. Pressure from        the balloon is sufficient to occlude small arterioles.        Furthermore, the center of this device may have a hollow        catheter for injection of thrombogenic agents such as thrombin,        which will flow over the surface of the balloon to promote        hemostasis. The same central catheter is used for aspiration of        the cavity contents, after the balloon has been deflated. It is        also connected to a pressure transducer to monitor intracranial        pressure.

The present invention provides systems that include the wire containingprobe 670 and a probe actuating subsystem described below. An exemplarysystem is shown in FIG. 13. The various components of the system aredescribed below.

Probe Device

The probe 670 is the device that may be inserted through the cannula tocut, fragment, cauterize and/or aspirate the mass. An exemplaryembodiment is shown in FIGS. 14-17 with reference to FIG. 13. Theembodiments described below are in reference to FIGS. 14-17 and aremerely exemplary. The four expanding loops (wires 674) are connected tothe central stem 620 at the distal end 676 and are pushed from theirresting state into loops by a motorized loop expander mechanism 694mounted on the probe outer sleeve 672. The proximal ends of these loopsare connected to the RF generator 680 via connection 696 (FIGS. 13 and15). The central stem 620 of the probe contains the suction channel orslot 702 and the slotted cutting tube 704 (see FIGS. 14 and 16). Theproximal end of this inner suction tube is connected to the controller682 (FIG. 13) and thru switching valves to the vacuum source 684 (FIG.13). The filter 707 is connected to the controller 682 and to a tissuecollection container 708 (FIG. 13). Through the controller's switchingvalve mechanism, the irrigation fluid from irrigation supply 686 (FIG.13) is channeled thru the central stem and delivered to the region. Theproximal section of the probe is also coupled to a motorized loopexpander and rotation mechanism 694. The expansion of the loops can besynchronized with rotation of the probe as well as with the applicationof the RF energy via RF connection 696. This provides for cutting,cauterizing and fragmentation of the mass simultaneously. The probemechanism is secured in its position thru attachment to thenavigation/guidance mount sub-system 600. The cannula 600 can also beinserted and secured with a robotic arm. The proximal ends of the loopsmay be securely connected to an Elevator mechanism 695 (FIG. 15).

The motorized loop expander and rotation mechanism 694 is gear coupledto the vertical gear section of the elevator 695 (FIG. 15). Thehorizontal gear section of the elevator is also coupled to innerhorizontal gears of the probe outer sleeve. The rotation of themotorized loop expander and rotation mechanism 694 rotates the elevatorwhich causes the probes to be pushed down resulting in their expansionsince the loops are swivel-fixed to the distal end 676 of the probe. Theelevator also rotates as it moves down, resulting in simultaneousrotation of the probe and its loops. The RF power 696 is coupled to themetallic elevator 695 as shown in FIG. 15, and therefore, to the loops674. The probe outer sleeve 672 is plastic and acts as the electricalinsulation between the loops and inner cutting tube as well as providingfor external isolation for the surgeon and brain tissue. The irrigationfluid from supply 686 is pumped in and delivered to the region throughinner vertical channels of the probe sleeve. This results in cut,coagulation and fragmentation of the target tissue. Once the loops areexpanded to the target diameter (e.g., as determined in pre-op planningusing CT or MR scan images) the motorized action is ceased. The loopsare held in expanded position and will serve as hold-back mechanism tokeep the tissue edges in place while the fragmented mass is aspirated.This avoids inadvertent collapse of the cavity when the suctionmechanism is activated.

The cutting motor is gear-coupled to the gears on the inner cuttingtube's 711 proximal end. The aspiration of fragmented mass is nextaccomplished by rotation of the inner cutting tube 711 inside the probesleeve while the system controller synchronously applies suction andirrigation fluid (FIGS. 15 and 16). The loops may be made from Nitinolwire and can be secured and fixed to the distal tip 676 via a loopswivel attachment 677 free to swivel and pivot when their proximal endis pushed down by the elevator mechanism 695. The hematomas or tumormass 709 (FIG. 12) is pulled into the suction slot 702 upon applicationof vacuum when both probe sleeve and inner cutting tube slots 704 arelined up. The rotation by cutting motor mechanism 706 of the innercutting tube's 711 slots 704 with respect to stationary probe sleeve'sslots 702 severs the tissue already pulled into the tube (side-cuttingaction). The smaller fragments of the tissue are aspirated without theneed for cutting action, but with the help of irrigation fluid. Finallythe rotational collapse of the loops 674, while aspiration in progress,also helps move the mass toward the central stem and suction slots.

The expanded diameter of the loops is set by probe extension past thedistal end 601 of the cannula 600. The cannula's distal end ispositioned at the edge of the target mass. The probe sleeve's externalthreading 673 interlocks with the cannula internal threading to set thisdiameter (FIG. 17). Once the loops are fully collapsed into theirinitial position, then the probe could be retracted. The balloon can nowbe inserted to start the next phase as described earlier.

Controller

In some embodiments, the systems of the present invention contain acontroller 682. An exemplary controller is described as follows. Thecontroller inter-connects the probe, RF generator, irrigation supply andvacuum source. It contains the electronic as well as electro-pneumaticinterfaces and controlling mechanism to facilitate cutting, cauterizing,fragmenting and aspirating the mass. Different modes and sequences ofoperation are selected thru its front panel controls by a surgeon. Italso contains a pressure transducer to measure and control theintracranial pressure.

RF Generator

In some embodiments, the systems of the present invention contain an RFgenerator 680 or other energy type generator. An exemplary RF generatoris manufactured by PEAK Surgical (Palo Alto, Calif.). The PULSAR®generator supplies short pulsed electrical discharges and allows theProbe to cut at much lower average temperatures than conventionalelectrosurgery without sticking.

Guidance/Navigation

In some embodiments, the systems of the present invention contain aguidance/navigation component. The device placement may be aided by anoff-the-shelf navigation/guidance system such as STEALTH or BRAINLAB.

Alternative Embodiments

The present invention is not limited to the cannula device, cutting andcauterizing device, aspiration device, and hemostasis promoting deviceembodiments described above and as shown in the figures. It iscontemplated that devices may be provided that are combinations of thedevices of the present invention. For example, the cutting andcauterizing device and aspiration device may be combined into onedevice. The cutting and cauterizing device and hemostasis promotingdevice may be combined into one device. The aspiration device andhemostasis promoting device may be combined into one device. The cuttingand cauterizing device, aspiration device, and hemostasis promotingdevice may be combined into one device. Additionally, the cutting andcauterizing device may be combine with both the aspiration device andthe hemostasis promoting device.

In preferred embodiments, it is contemplated that any kind of surgicalinstrument may be used with the cannula devices of the presentinvention. For example, buttoned probes, ablation devices (e.g., laserablation devices, cryo-ablation devices, electrical ablation devices,radio-frequency ablation devices, ultrasound ablation devices, thermalablation devices), imaging devices (e.g., endoscopic devices,stereotactic computer assisted neurosurgical navigation devices, andintraoperative magnetic resonance imaging), implanted deep-brainstimulation (DBS) systems and spinal cord stimulation systems, vesseldilators, curettes, scoops, dissectors, micro forceps, suture tyingforceps, ligature guides and carriers, ligature needles, micro needleholders, nerve and vessel hooks, raspatories, rhoton needles, microscissors, tissue claws, vessel clips, vessel claws, vessel spreaders,brain spatulas, bulldog clamps, chisels, drills, tumor grasping forceps,galea hooks, magnifying glasses, puncture needles, rongeurs may all beused with the cannula devices of the present invention in someembodiments of the present invention.

It is contemplated that the devices of the present invention may becombined within various system embodiments. For example, the presentinvention contemplates a system comprising the cannula device and anysurgical instrument (e.g., ablative device (see, e.g., U.S. Pat. No.5,554,110; herein incorporated by reference in its entirety), imagingdevices (see, e.g., U.S. Pat. Nos. 6,817,976 and 5,697,949; each hereinincorporated by reference in their entireties), resectoscope devices(see, e.g., U.S. Pat. No. 6,824,544; herein incorporated by reference inits entirety); the cutting and cauterizing devices of the presentinvention, ultrasonic tissue resectors (see, e.g., U.S. Pat. No.5,772,627; herein incorporated by reference in its entirety), endoscopicelectric cautery devices (see, e.g., U.S. Pat. No. 6,086,583; hereinincorporated by reference in its entirety), cerebral surgery apparatuses(see, e.g., U.S. Pat. No. 5,154,723; herein incorporated by reference inits entirety); pressure hemostatic devices (see, e.g., Japanese PatentAbstract No. 2004223032; herein incorporated by reference in itsentirety), the aspiration devices of the present invention, thehemostasis promoting devices of the present invention, and/or anycombinations thereof) positioned within the cannula device.

Additionally, it is contemplated that the devices of the presentinvention may be combined within various kit embodiments. For example,the present invention contemplates kits comprising the cannula devicealong with any one or more accessory agents. The present invention isnot limited to any particular accessory agent. For example, accessoryagents include but are not limited to ablation devices, imaging devices,resection devices (e.g., the cutting and cauterizing device of thepresent invention), aspiration devices (e.g., the aspiration device ofthe present invention), hemostasis promoting devices (e.g., thehemostasis promoting device of the present invention), and/or anycombinations thereof. Additionally, the present invention contemplateskits comprising instructions (e.g., surgical instructions,pharmaceutical instructions) along with the cannula device of thepresent invention along with a pharmaceutical agent (e.g., aneurological medication).

Additionally, it is contemplated that the devices of the presentinvention may be combined within various kits or system embodiments. Forexample, the kits or systems may comprise a device comprising a cannulamember, and a device comprising a cutting and cauterizing member, anaspiration member, and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, adevice comprising a cutting and cauterizing member, a device comprisingan aspiration member, and a device comprising a hemostasis member. Inpreferred embodiments, the kit or system comprises a device comprising acannula member, a device comprising a cutting and cauterizing member,and a device comprising an aspiration member. In preferred embodiments,the kit or system comprises a device comprising a cannula member, adevice comprising a cutting and cauterizing member, and a devicecomprising a hemostasis member. In preferred embodiments, the kit orsystem comprises a device comprising a cannula member, a devicecomprising an aspiration member, and a device comprising a hemostasismember. In preferred embodiments, the kit or system comprises a devicecomprising a cutting and cauterizing member and an aspiration member. Inpreferred embodiments, the kit or system comprises a device comprisingan aspiration member and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cutting andcauterizing member and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cutting andcauterizing member and an aspiration member, and a device comprising ahemostasis member. In preferred embodiments, the kit or system comprisesa device comprising an aspiration member and a hemostasis member, and adevice comprising a cutting and cauterizing member. In preferredembodiments, the kit or system comprises a device comprising a cuttingand cauterizing member and a hemostasis member, and a device comprisingan aspiration member. In preferred embodiments, the kit or systemcomprises a device comprising a cutting and cauterizing member, anaspiration member, and a hemostasis member. In preferred embodiments,the kit or system comprises a device comprising a cutting andcauterizing member, a device comprising an aspiration member, and adevice comprising a hemostasis member. In preferred embodiments, the kitor system comprises a device comprising a cutting and cauterizingmember, and a device comprising an aspiration member. In preferredembodiments, the kit or system comprises a device comprising a cuttingand cauterizing member, and a device comprising a hemostasis member. Inpreferred embodiments, the kit or system comprises a device comprisingan aspiration member, and a device comprising a hemostasis member.

Uses

The devices of the present invention provide numerous advantages overthe prior art. Generally, the surgical procedure for the removal of atissue mass (e.g., a brain tumor) involves a large incision on asubject's head followed by the removal of a piece of cranium. The brainis next uncovered by cutting the dura matter and ultimately the removalof the tissue mass through openings in the brain (e.g., pia). For largetumors that contact the surface of a brain, surgically creating a largeopening in the pia is necessary. For deeply seated brain tumors,however, surgically creating a large opening in the pia extending to adeeply seated area presents an enormous risk to the subject (e.g., riskof brain damage). As such, accessing deeply seated brain tumors requiresthe surgical creation of small and narrow brain openings so as to avoidpotential brain damage.

The devices of the present invention overcome this limitation within theprior art. In particular, the cannula device of the present inventionprovides a secured small and narrow opening from an opening in thecranium (e.g., burr hole) through the brain to a deeply seated area. Thecannula may be secured in place to allow multiple different tools toreadily access a specific region of the brain to be treated.

The devices of the present invention may be used in any surgical orneurosurgical technique (e.g., surgical method). In preferredembodiments, the devices of the present invention may be used to treat(e.g., excise, aspirate, cut, biopsy, image, cauterize, ablate) braintumors, unwanted brain masses, hematomas, infracted or damaged braintissue, infections and unwanted brain lesions. The present invention isnot limited to the treatment of a specific type of brain tumor. Indeed,any type of brain tumor may be treated with the devices of the presentinvention, including but not limited to metastatic brain tumors,astrocytoma tumors, glioma tumors, atypical teratoid I rhabdoid tumors,brain stem gliomas, choroid plexus tumors, craniopharyngiomas,ependymoma tumors, ganglioglioma tumors, germ cell tumors, gliomatosiscerbri tumors, infant brain tumors, medulloblastoma tumors,oligodendroglioma tumors, and optic pathway tumors. Additionally, as thedevices of the present invention are not limited to neurosurgicalapplications, the devices of the present invention may be used to treat(e.g., excise, aspirate, cut, image, cauterize, ablate) tumors, unwantedtissue masses, and unwanted tissue lesions located at any locationwithin a body (e.g., liver, spinal cord, heart, lungs, bones, etc.).

It is also contemplated the devices of the present invention may be usedas a form of treatment for diseases and disorders (e.g., brain cancer,aneurysm, strokes, brain trauma). In some preferred embodiments, it iscontemplated the devices of the present invention may be used to deliverpharmaceutical agents to locations within a body (e.g., the brain). Insome preferred embodiments, it is contemplated the devices of thepresent invention may be used to deliver therapeutic agents or tissuesuch as stem cells or immune cells to locations within a body (e.g., thebrain).

Example

This example describes a contemplated surgical method for removing adeeply seated brain tumor utilizing the devices of the presentinvention. While this example describes the excision of a brain tumor,the technique may be applied to any unwanted brain mass or unwantedbrain lesion. First, a burr hole is placed within the cranium. Second,one of the cannula devices of the present invention is secured withinthe burr hole (see, e.g., FIGS. 1-3). The cannula device provides asmall and narrow passageway leading directly to the surface of the braintumor. Additionally, the cannula device provides a point of access forthe insertion of surgical instruments. Third, tumor biopsy instrumentsare passed through the cannula device and a biopsy of the brain tumor iscompleted. Fourth, tumor fragmentation instruments (e.g., ablationinstruments) are passed through the cannula device and the brain tumoris fragmented. Fifth, one of the cutting and cauterizing devices of thepresent invention is passed through the cannula device, the brain tumoris cut from the surrounding brain tissue, and the brain tumor surfacecauterized (see, e.g., FIGS. 4-6). Sixth, one of the aspiration devicesof the present invention is passed through the cannula device and thefragmented brain tumor is aspirated (see, e.g., FIGS. 7-9). Seventh, oneof the hemostasis promoting devices is passed through the cannula deviceand hemostasis is induced upon the surrounding brain tissue (see, e.g.,FIGS. 10-11).

All publications and patents mentioned in the above specification areherein incorporated by reference. Although the invention has beendescribed in connection with specific preferred embodiments, it shouldbe understood that the invention as claimed should not be unduly limitedto such specific embodiments. Indeed, various modifications of thedescribed modes for carrying out the invention that are obvious to thoseskilled in the relevant fields are intended to be within the scope ofthe following claims.

1. A brain probe device for use in removing a lesion from a brain of apatient, the brain probe device comprising: a first tube having a firsttube lumen and first tube tissue removal openings; a second tubedisposed within the first tube and having a second tube lumen and secondtube radial openings configured to cooperate with the first tube tissueremoval openings to cut tissue and allow aspiration of the cut tissuethrough the second tube lumen via the first tube tissue removal openingsand the second tube radial openings; a probe sleeve having a proximalportion that encloses a portion of the first tube; wire loops attachedto a distal end of the first tube and configured to be outwardlyexpanded from the first tube and rotated to cut tissue; a loop expanderand rotation mechanism drivingly coupled with the wire loops and thefirst tube, the loop expander and rotation mechanism being operable to:simultaneously expand the wire loops while rotating the first tube andthe wire loops; and simultaneously contract the wire loops whilerotating the first tube and the wire loops; an aspiration port in fluidcommunication with the second tube lumen for aspiration of the cuttissue; and an irrigation port for transferring irrigation fluid toirrigate the cut tissue in synchrony with aspiration of the cut tissue.2. The brain probe device of claim 1, wherein: the loop expander androtation mechanism is mounted to the probe sleeve; the loop expander androtation mechanism is operable to expand the wire loops by movingproximal ends of the wire loops toward a distal end of the first tube;and the loop expander and rotation mechanism is operable to contract thewire loops by moving the proximal ends of the wire loops away from thedistal end of the first tube.
 3. The brain probe device of claim 2,wherein: the proximal ends of the wire loops are drivingly coupled witha splined elevator member disposed inside the probe sleeve andconfigured to translate relative to the probe sleeve when the splinedelevator member is rotated relative to the probe sleeve by the loopexpander and rotation mechanism; and the loop expander and rotationmechanism comprises a first gear interfaced with the splined elevatormember so that rotation of the first gear rotates the splined elevatormember relative to the probe sleeve and the splined elevator member isconfigured to accommodate translation of the splined elevator memberrelative to the probe sleeve.
 4. The brain probe device of claim 1,further comprising a second tube rotation mechanism operable to rotatethe second tube relative to the probe sleeve independent of rotation ofthe first tube relative to the probe sleeve by the loop expander androtation mechanism.
 5. The brain probe device of claim 1, wherein eachof the wire loops has a proximal portion and a distal portion, andwherein the loop expander and rotation mechanism is configured tocontrollably displace the proximal portion of each of the wire loopsdistally so as to outwardly expand the wire loops from a contractedconfiguration to a preset expanded configuration.
 6. The brain probedevice of claim 1, further comprising an energy generator connectionoperatively coupled with at least one of the wire loops for transferringradiofrequency (RF) energy from an RF energy source to the at least oneof the wire loops.
 7. The brain probe device of claim 1, furthercomprising a cannula sized and shaped so that probe sleeve can beinserted through the cannula.
 8. The brain probe device of claim 1,wherein the first tube is positionable lengthwise within the probesleeve to select a maximum outward expansion amount of the wire loops.9. The brain probe device of claim 8, wherein first tube is coupled withthe probe sleeve so that a rotation of the first tube relative to theprobe sleeve repositions the first tube lengthwise relative to the probesleeve.
 10. The brain probe device of claim 1, further comprising acontroller configured to control an irrigation fluid source and anaspiration mechanism to synchronize supply of irrigation fluid to theirrigation port with the aspiration of the cut tissue via the aspirationport.
 11. A method for removing a lesion from a brain of a patient, themethod comprising: positioning wire loops of a brain probe devicerelative to the lesion; simultaneously rotating and expanding the wireloops to cut tissue from the lesion; simultaneously supplying irrigationfluid via the brain probe device to irrigate the tissue cut from thelesion and aspirating at least some of the irrigation fluid via thebrain probe device to facilitate removal of the tissue cut from thelesion.
 12. The method of claim 11, further comprising simultaneouslyrotating and contracting the wire loops to position tissue cut from thelesion for removal through an aspiration lumen of the brain probedevice.
 13. The method of claim 12, further comprising rotating a firsttube of the brain probe device relative to a second tube of the brainprobe device to further cut the tissue cut from the lesion by the wireloops to facilitate aspiration of the tissue cut from the lesion throughthe aspiration lumen.
 14. The method of claim 11, wherein simultaneouslyrotating and expanding the wire loops to cut tissue from the lesioncomprises rotating and translating a splined elevator member drivinglycoupled with the wire loops relative to a probe sleeve in which thesplined elevator member is disposed and to which the splined elevatormember is coupled so that rotation of the splined elevator memberrelative to the probe sleeve translates the splined elevator memberrelative to the probe sleeve.
 15. The method of claim 11, comprisingapplying RF energy to at least one of the wire loops to facilitatecutting tissue from the lesion.
 16. The method of claim 11, furthercomprising: surgically removing a portion of a skull of the patient toproduce an aperture in the skull for access to the brain; inserting atubular extension of a cannula through the aperture; and affixing thecannula to the skull to maintain alignment of the tubular extension withthe lesion, and wherein positioning the wire loops relative to thelesion comprises inserting the brain probe device through the tubularextension.
 17. The method of claim 11, further comprising adjusting thebrain probe device to select a maximum outward expansion amount of thewire loops.
 18. The method of claim 17, wherein: adjusting the brainprobe device to select a maximum outward expansion amount of the wireloops comprises repositioning a first tube of the brain probe devicelengthwise relative to a probe sleeve of the brain probe device; anddistal ends of the wire loops are attached to a distal end of the firsttube.
 19. The method of claim 18, wherein repositioning the first tubelengthwise relative to the probe sleeve comprises rotating the firsttube relative to the probe sleeve.
 20. The method of claim 11, furthercomprising controlling an irrigation fluid source and an aspirationmechanism to synchronize supply of irrigation fluid to irrigate thetissue cut from the lesion with aspiration of the tissue cut from thelesion and at least some of the irrigation fluid to control intracranialpressure.